3rd MEETING OF DRUG REGULATORY AUTHORITIES OF CENTRAL AND EASTERN EUROPEAN COUNTRIES
28 - 29 March 1999
BRATISLAVA - ČASTÁ PAPIERNIČKA, SLOVAK REPUBLIC
CADREAC: The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries
THE AGENDA FOR CADREAC MEETING
SUNDAY, 28. March 1999
8.30 - 9.00 Opening Remarks, adoption of the Agenda - Ass. prof. Ľudevít Martinec
9.00 - 10.30 Cooperation among CEEC DRAs (CADREAC collaboration) Experience, Information dissemination, Perspectives (institutionalisation, administration, working groups, internet
10.30 - 11.00 Coffee break Closed session CADREAC DRAs and observers from: Russia, Belorussia, Ukraine, Croatia and NIS, other ex-Jugoslavia countries
11.00 - 12.00 Results of negotiations of CEECs with EC on "acquis communitaire in pharmaceutical sector“ Identifying main problems of the DRAs in CADREAC countries at the current stage of development.
12.00 - 12.30 Information about International Reviewers Forum Perspective of electronic submissions
12.30 - 13.30 Lunch
13.30 - 16.00 The CEECs observers by EMEA and EC committees and working parties (Experiences, Information dissemination, Nomination of the observers for the following period
16.00 - 16.30 Coffee break
16.30 - 17.00 Pan European Regulatory Forum (Information, Participation in working parties, Proposed topics)
17.00 - 17.30 Pharmaceutical inspection, Experience with the collaboration, Joint - inspection, Mutual recognition negotiation with EC, PECAS
MONDAY, 29. March 1999
8.30 - 9.00 EU enlargement - status and future development
9.00 -10.00 Participation of the CADREAC DRAs in EC and EMEA committees and working parties (View of the EMEA and EC)
10.00 - 10.30 The scope and the role of DRA
10.30 - 11.00 Coffee break
11.00 - 11.30 Simplified procedure for marketing authorisation of medicinal products authorised in the EU following the centralised procedure and for variations and renewals to these marketing authorisations in CEECs (Implementation of the SOP and postmarketing survielance)
11.30 - 12.30 EU mutual recognition procedure. - Possibility of recognitions (Status of EU mutual recognition procedure in CADREAC countries. Proposals on future steps towards harmonised recognition of the procedure by CADREAC countries)
12.30 - 13.30 Lunch
13.30 - 14.00 Renewals of generic applications - prof. Tamas Paál
14.00 - 14.30 International Conference of Drug Regulatory Authorities (ICDRA) Kees de Joncheere, WHO
14.30 - 16.30 Pan European Regulatory Forum (Meeting of participating members of Pan European Regulatory Forum Steering committee)
16.30 - 17.00 Conclussion
